Apply on Employer Site

WSA – Wonderful Sound for All · 1 month ago

Quality Assurance Specialist, Designated Complaint Unit (Americas) - Hybrid

Iselin, NJ

Full-time

Hybrid

New Grad, Entry Level

$70K/yr - $90K/yr

WSA is a global leader in the hearing aid industry, inviting candidates to help unlock human potential by improving hearing for millions. The Quality Assurance Specialist will work within a multicultural team to manage customer complaints, ensuring they are processed according to regulatory requirements.

ElectronicsIndustrialManufacturingMedical Device

Responsibilities

Serve as part of the America’s DCU working in a Global and multicultural Team that ensures customer complaints are captured, assessed for reportability, processed and resolved in a timely manner as per applicable internal and regulatory requirements

Perform initial screening of new complaints to determine potential reportability, investigator and appropriate investigation location. Process local device return logistics for complaint handling

Perform follow-ups with investigators, LPOC’s and other partners to ensure complaints are processed in a timely manner

Continuously review complaint files to ensure documentation is aligned according to requirements (internal/external) and good documentation practices

Perform final review of complaint files to ensure all activities were completed and documented accordingly

Provide input on Global Projects and process improvements related to complaint handling

Provide support for stakeholders and ensure that Global complaint process inspections and audits (internal and external) are effectively managed

Serve as a contact person to local Customer Service, Affiliates and LPOC’s to ensure all appropriate complaint information is received for day-to-day complaint handling

Be available for early morning calls with global Team 1-2x per month

Qualification

Complaint Handling processesFDA regulationsISO 13485Microsoft OfficeSalesforceLeadership capabilitiesProblem-solving skillsTime management skillsTeam playerWork independently